Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Tadalafil Versus Placebo in Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology (TRIUMPH Trial)

The purpose of this study is to find out more about the effectiveness of Tadalafil in improving hemodynamic capabilities, endothelial function, and end-organ function in patients who have previously undergone a Fontan Palliation.

Inclusion Criteria:

• Patients ≥ 18 years old.
• Have previously undergone a Fontan Palliation.
• Able to exercise using a supine bike.
• Ability and willingness to provide written consent.
• Undergoing a clinically indicated Cardiac Catheterization

Exclusion Criteria:

• Patients < 18 years old.
• Current intravenous inotropic drugs.
• Current use of alpha-blockers, pulmonary vasodilators, or nitrates.
• Unable to exercise.
• Pregnancy or lactating.
• Unable or unwilling to consent.